Recombinant Factor VIIa is indicated for:
- Treatment of bleeding episodes and perioperative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.
- Treatment of bleeding episodes and perioperative management in adults with acquired hemophilia.
Dosing for bleeding in approved indications:-
Indication |
Dosing Recommendation |
Congenital Hemophilia A or B with Inhibitors |
- 90 mcg/kg every 2 hours, adjustable based on severity of bleeding until hemostasis is achieved
- 90 mcg/kg every 3-6 hours after hemostasis is achieved for severe bleeds
|
Acquired Hemophilia |
- 70-90 mcg/kg every 2-3 hours until hemostasis is achieved
|
Congenital Factor VII Deficiency |
- 15-30 mcg/kg every 4-6 hours until hemostasis is achieved
|
Glanzmann’s Thrombasthenia |
- 90 mcg/kg every 2-6 hours until hemostasis is achieved
|
Dosing for Peri-operative management in approved indications:-
Indication |
Dosing Recommendation |
Congenital Hemophilia A or B with Inhibitors |
Minor:
- 90 mcg/kg immediately before surgery, repeat every 2 hours during surgery
- 90 mcg/kg every 2 hours after surgery for 48 hours, then every 2-6 hours until healing has occurred
Major:
- 90 mcg/kg immediately before surgery, repeat every 2 hours during surgery
- 90 mcg/kg every 2 hours after surgery for 5 days, then every 4 hours until healing has occurred
|
Acquired Hemophilia |
- 70-90 mcg/kg immediately before surgery and every 2-3 hours for the duration of surgery and until hemostasis is achieved
|
Congenital Factor VII Deficiency |
- 15-30 mcg/kg immediately before surgery and every 4-6 hours for the duration of surgery and until hemostasis is achieved
|
Glanzmann’s Thrombasthenia |
- 90 mcg/kg immediately before surgery and repeat every 2 hours for the duration of the procedure
- 90 mcg/kg every 2-6 hours to prevent post-operative bleeding
|
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